Proposed Collection; 60-Day Comment Request; Intramural Continuing Umbrella of Research Experiences (iCURE) Application (National Cancer Institute), 35665-35666 [2018-16053]
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Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
6. European National Stage Patent
Application. (No. not yet assigned), filed
April 30, 2018 [HHS Ref. No. E–187–
2015/0–EP–06];
7. U.S. National Stage Patent Application No.
15/771,932, filed April 30, 2018 [HHS
Ref. No. E–187–2015/0–US–07];
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cancer
Immunotherapy
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. Patents and Patent Applications
listed in the Supplementary Information
section of this notice to Midissia
Therapeutics (‘‘Midissia’’) located in
San Francisco, CA.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before August 13, 2018 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Ricquita Pollard,
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240) 276–5530;
Facsimile: (240) 276–5504; Email:
pollardrd@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Intellectual Property
1. United States Provisional Patent
Application No. 62/248,964 filed Oct. 30,
2015 for ‘‘Compositions and Methods for
the Treatment of HER2-Expressing Solid
Tumor ‘‘[HHS Ref. No. E–187–2015/
0US–01];
2. International Patent Application No. PCT/
US2016/059680 filed October 31, 2016
for ‘‘Compositions and Methods for
Treatment of HER2-Expressing Solid
Tumor’’ [HHS Reference No. E–187–
2015/0–PCT–02];
3. Canadian National Stage Patent
Application (No. not yet assigned), filed
April 30, 2018 [HHS Ref. No. E–187–
2015/0–CA–03];
4. Japanese National Stage Patent Application
No. 2018–521518, filed April 30, 2018
[HHS Ref. No. E–187–2015/0–JP–04];
5. Australian National Stage Patent
Application No. 2016343845, filed April
30, 2018 [HHS Ref. No. E–187–2015/0–
AU–05];
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17:38 Jul 26, 2018
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The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to
‘‘development and commercialization of
Ad-HER2 vaccines as a therapeutic
against HER2-positive cancers as
covered within the scope of the
Licensed Patent Rights, excluding uses
in combination with vectors/adjuvants,
checkpoint inhibitors or other immune
modulators.’’
This technology describes a
recombinant adenoviral vector that
expresses the extracellular (EC) and
transmembrane (TM) domains of the
human HER2 protein and is designed to
induce a polyclonal anti-tumor
response. HER2 is a member of the
epidermal growth factor family and is
overexpressed in subsets of breast,
ovarian, gastric, colorectal, pancreatic
and endometrial cancers. This vaccine
encodes for the entire EC and TM
domains of human HER2neu and is
specifically contained within a
recombinant adenoviral vector that has
the knob of Adenovirus 5 and
substituted fiber of Adenovirus 35. The
substitution of the knob of Adenovirus
35 whose receptor is CD46 allows for
efficient and maximal transduction of
human dendritic and hematopoietic
cells.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
PO 00000
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Fmt 4703
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35665
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: July 19, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2018–16058 Filed 7–26–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Intramural Continuing
Umbrella of Research Experiences
(iCURE) Application (National Cancer
Institute)
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Alison Lin, 9609 Medical
Center Drive, Rockville, MD 20850 or
call non-toll-free number (240) 276–
6177 or Email your request, including
your address to: linaj@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
SUMMARY:
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35666
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Intramural
Continuing Umbrella of Research
Experiences (iCURE) Application, 0925–
XXXX, Exp., Date XX/XXXX, EXISTING
COLLECTION IN USE WITHOUT OMB
APPROVAL, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The new Intramural
Continuing Umbrella of Research
Experiences (iCURE) program supports
mentored research experiences for
qualified post-baccalaureate (including
post masters) individuals, graduate
students, and postdoctoral fellows in
the multidisciplinary National Cancer
Institute (NCI) intramural research
environment. This information
collection request are applications and a
reference letter to help evaluate the
merits of the candidates and their
potential match for the iCURE program.
iCURE is an extension of the highly
successful NCI Center to Reduce Cancer
Health Disparities’ (CRCHD) Continuing
Umbrella of Research Experiences
(CURE) program which helps support
the career progress of its scholars
toward research independence, as well
as fosters and sustains diversity in the
biomedical research pipeline. Like the
CURE program, iCURE strongly
encourages the participation of
individuals from underrepresented
populations and is aligned with NCI’s
interest in diversity. The benefit of
collecting this information is to enable
the selection of the best matching
candidates for the iCURE program. The
iCURE program aims to, 1. Enhance the
diversity of the NCI Intramural Research
Program (IRP), and 2. Promote the career
progress of the iCURE scholars in cancer
research.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated burden hours are 305.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
time per
response
(in hours)
Total annual
burden hour
Form name
Type of respondent
Postbac Supplemental Application ...
50
1
30/60
25
Graduate Student Application ...........
Postdoctoral Fellowship Application
Reference Letter ...............................
Post-Baccalaureate (Including PostMaster’s) Individuals.
Graduate Students ...........................
Postdoctoral Candidates ..................
PIs, professors, supervisors .............
30
50
240
1
1
1
2
2
30/60
60
100
120
Total ...........................................
...........................................................
370
370
........................
305
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2018–16053 Filed 7–26–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke, Muscular
Dystrophy Coordinating Committee
Call for Committee Membership
Nominations
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Office of the Secretary of
the Department of Health and Human
Services (HHS) is seeking nominations
for an individual to serve as a
nonfederal public member on the
Muscular Dystrophy Coordinating
Committee.
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
Nominations are due by 5 p.m.
EDT on August 31, 2018.
DATES:
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17:38 Jul 26, 2018
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Nominations must be sent
to Glen Nuckolls, Ph.D., by email to
nuckollg@ninds.nih.gov.
FOR FURTHER INFORMATION CONTACT: Glen
Nuckolls, Ph.D., by email to nuckollg@
ninds.nih.gov. or (301) 496–5745.
SUPPLEMENTARY INFORMATION: The
Muscular Dystrophy Coordinating
Committee (MDCC) is a federal advisory
committee established in accordance
with the Muscular Dystrophy
Community Assistance, Research, and
Education Amendments of 2001 (MD–
CARE Act; Pub. L. 107–84). The MD–
CARE Act was reauthorized in 2008 by
Public Law 110–361, and again in 2014
by Public Law 113–166. The MD–CARE
Act specifies that the committee
membership be composed of 2⁄3
governmental agency representatives
and 1⁄3 public members. We are seeking
nominations for two non-federal, public
members at this time, due to turnover of
committee membership. Nominations
will be accepted between July 31 and
August 31, 2018.
Who is Eligible: Nominations are
encouraged for new or reappointment of
non-federal public members who can
provide the public and/or patient
perspectives to discussions of issues
considered by the Committee. SelfADDRESSES:
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Fmt 4703
Sfmt 4703
nominations and nominations of other
individuals are both permitted. Only
one nomination per individual is
required. Multiple nominations for the
same individual will not increase
likelihood of selection. Non-federal,
public members may be selected from
the pool of submitted nominations or
other sources as needed to meet
statutory requirements and to form a
balanced committee that represents the
diversity within the muscular dystrophy
communities. Nominations are
especially encouraged from leaders or
representatives of muscular dystrophy
research, advocacy, or service
organizations, individuals with
muscular dystrophy or their parents or
guardians. In accordance with White
House Office of Management and
Budget guidelines (FR Doc. 2014–
19140), federally-registered lobbyists are
not eligible.
Committee Composition: The
Department strives to ensure that the
membership of HHS Federal advisory
committees is fairly balanced in terms of
points of view represented and the
committee’s function. Every effort is
made to ensure that the views of all
genders, all ethnic and racial groups,
and people with disabilities are
E:\FR\FM\27JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35665-35666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Intramural
Continuing Umbrella of Research Experiences (iCURE) Application
(National Cancer Institute)
AGENCY: National Institutes of Health, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Cancer Institute (NCI) will publish
periodic summaries of propose projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Alison Lin,
9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free
number (240) 276-6177 or Email your request, including your address to:
[email protected]. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
[[Page 35666]]
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Intramural Continuing Umbrella of
Research Experiences (iCURE) Application, 0925-XXXX, Exp., Date XX/
XXXX, EXISTING COLLECTION IN USE WITHOUT OMB APPROVAL, National Cancer
Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The new Intramural
Continuing Umbrella of Research Experiences (iCURE) program supports
mentored research experiences for qualified post-baccalaureate
(including post masters) individuals, graduate students, and
postdoctoral fellows in the multidisciplinary National Cancer Institute
(NCI) intramural research environment. This information collection
request are applications and a reference letter to help evaluate the
merits of the candidates and their potential match for the iCURE
program. iCURE is an extension of the highly successful NCI Center to
Reduce Cancer Health Disparities' (CRCHD) Continuing Umbrella of
Research Experiences (CURE) program which helps support the career
progress of its scholars toward research independence, as well as
fosters and sustains diversity in the biomedical research pipeline.
Like the CURE program, iCURE strongly encourages the participation of
individuals from underrepresented populations and is aligned with NCI's
interest in diversity. The benefit of collecting this information is to
enable the selection of the best matching candidates for the iCURE
program. The iCURE program aims to, 1. Enhance the diversity of the NCI
Intramural Research Program (IRP), and 2. Promote the career progress
of the iCURE scholars in cancer research.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated burden hours are
305.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Postbac Supplemental Post- 50 1 30/60 25
Application. Baccalaureate
(Including Post-
Master's)
Individuals.
Graduate Student Application.. Graduate 30 1 2 60
Students.
Postdoctoral Fellowship Postdoctoral 50 1 2 100
Application. Candidates.
Reference Letter.............. PIs, professors, 240 1 30/60 120
supervisors.
---------------------------------------------------------------
Total..................... ................ 370 370 .............. 305
----------------------------------------------------------------------------------------------------------------
Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2018-16053 Filed 7-26-18; 8:45 am]
BILLING CODE 4140-01-P
